DAYTIME COLD FLU NON DROWSY- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

DayTime Cold Flu by

Drug Labeling and Warnings

DayTime Cold Flu by is a Otc medication manufactured, distributed, or labeled by Harris Teeter, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

• temporarily relieves common cold and flu symptoms:
• minor aches & pains
• headache
• sore throat
• nasal congestion
• fever 
• cough due to minor throat and bronchial irritation

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and sek medical help right away

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• liver disease
• diabetes  
• heart disease
• thyroid disease
• high blood pressure
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough as occurs with smoking, asthma, or emphysema 
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

• pain, cough, or nasal congestion gets worse or lasts more than 7 days
• nervousness, dizziness or sleeplessness occur 
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose can cause serious liver damage.In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms

Directions

• do not take more than directed (see overdose warning)
• do not take more than 4 doses in 24 hours
• adults and children 12 years and over: take 2 softgels with water every 4 hours
• swallow whole; do not crush, chew, or dissolve
• children under 12 years: do not use
• when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information

• store between 15_30oC (59-86oF)
• avoid excessive heat

Inactive ingredients

butylated hydroxyanisole, butylated hydroxytoluene, carminic acid*, edible white ink, D&C yellow #10*, FD&C Red #40*, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sodium metabisulfite*, sorbitan, sorbitol

contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

DayTime Non-Drowsy

Cold & Flu Relief 

MULTI-SYMPTOM RELIEF

Acetaminophen

Dextromethorphan

Phenylephrine

• ACHES, FEVER, SORE THROAT
• COUGH
• NASAL CONGESTION

Alcohol-Free

Antihistamine-Free

Softgels**

(**Liquid Filled Capsules)

†Compare to the active ingredients in Vicks® DayQuil® LiquiCaps®

†This product is not manufactured or distributed by the Procter & Gamble, Company. Vicks®, DayQuil® Liquicaps® are registered trademarks of The Procter & Gamble Company.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC

MATTHEWS, NC 28105

For ful details: 1-800-432-6111 or harristeeter.com

Product Label

Harris Teeter DayTime Non-Drowsy Cold & Flu Relief

INGREDIENTS AND APPEARANCE

DAYTIME COLD FLU  NON DROWSY
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69256-468
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
CARMINIC ACID (UNII: CID8Z8N95N)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	P19;95A;512;P119
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69256-468-24	24 in 1 CARTON	01/31/2016
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/31/2016

Labeler - Harris Teeter, LLC (048463103)